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Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors

NCT05813392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2024-10-22

No results posted yet for this study

Summary

To explore the efficacy of dCBT-I therapy for chronic insomnia among breast cancer survivors in China, we propose to conduct a randomized, parallel controlled clinical study in breast cancer survivors using a smartphone Chinese application (app) "resleep". Breast cancer survivors with chronic insomnia were recruited from our Breast Disease Center and externally, with the waiting group as a parallel control and the dCBT-I treatment group as an intervention group, in a 1:1 sample size. Intervention group (dCBT-I treatment group) will receive full self-help dCBT-I administered by smartphone APP for 6 weeks. The control group (waiting for treatment group) will not receive any additional interventions based on the original conventional treatment and will be followed up as planned, waiting for treatment.At the end of the 3-month follow-up, the decision to receive treatment was made according to the patient's wishes. The primary endpoint was the insomnia severity index (ISI) at the end of treatment and at 3 months of treatment.

Conditions

  • Chronic Insomnia

Interventions

BEHAVIORAL

Digital Cognitive Behavioral Therapy for Insomnia

a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP

Sponsors & Collaborators

  • Shenzhen Zeen Health Technology Co., Ltd.

    collaborator UNKNOWN

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2025-08-29
Completion
2026-08-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05813392 on ClinicalTrials.gov